The transplantation of human organs has been one of the biggest advances in the medical sciences in the last century. In India, it is governed by the Transplantation of Human Organs and Tissues Act, 1994.
Transplants are of two types and this Act deals with both — first, transplants from deceased persons; where organs have to be removed from a person whose brainstem is irreversibly damaged but vital organs are functioning. This act makes Brainstem Death (BSD) a legal entity, and lays down certain procedures to identify and certify such deaths.
Second, live donations, where a functioning organ is removed from a healthy person and transplanted to another human being. This too requires legal sanction because, doctors by their training and oath, are not empowered to remove a healthy organ from a normal person.
However, despite the Act being in force for over three decades, India’s performance remains dismal. By 2023, Spain was recording 49.38 deceased donations per million of population. For India it was 0.77. About half a million Indians die every year in need of transplantation.
Legal uncertainties
One reason for this dismal performance is the lack of clarity on legal issues surrounding BSD certification.
The first question is whether BSD can be legally treated as equivalent to a cardiac death. This doubt arises because the definition of BSD is provided only in the 1994 Act. There is a prevailing confusion if this definition can be applied in a situation where, after BSD certification, there is a stalemate because the family does not give consent to donate organs. Should this certificate be ignored and life support be continued till the heart stops? This is not just an academic question. In a country with a severe scarcity of ventilators, especially in public hospitals, maintaining a certified BSD person indefinitely is an unacceptable wastage of a precious resource.
If, on the other hand, the family consents to organ donation, should a fresh, conventional death certificate be issued after the organ harvest is completed? This is the current practice in most transplant centres. It results in a peculiar situation where one individual has two death certificates.
The answers to these questions are available in the 1994 Act itself. The Act defines “brain-stem death” as the stage at which all functions of the brain-stem have permanently and irreversibly ceased and is so certified.
A “deceased person” is a person in whom permanent disappearance of all evidence of life occurs, by reason of brain-stem death or in a cardio-pulmonary sense, at any time after live birth has taken place. The crucial phrase is “permanent disappearance of all evidence of life”.
That is, the Act recognises the fact that permanent disappearance of all evidence of life can occur both in BSD or in a cardio-pulmonary sense, and therefore accords BSD legal sanction.
On certifying death
Death is a terminal event and cannot be defined differently in different Acts. There are three steps with respect to death — it should be diagnosed, certified and then registered. While the first one is purely medical, the next two steps are legal. The legal steps have to be in consonance with each other.
Death is defined in the Registration of Birth and Death Act, 1969, which is the only other legal text where death is defined, as “the permanent disappearance of all evidence of life at any time after live-birth has taken place”. Both the 1969 and the 1994 Acts emphasise ‘permanent disappearance of all evidence of life’ as the core criterion. And since this can occur through BSD, a certificate issued under the provisions of the 1994 Act is a legal document, and is sufficient to register the death under the 1969 Act. No further amendments of the Act or Rules are needed to certify and register BSD as death.
The form that is required to register death — Form 4 under Rule 7 of the 1969 Act — further clarifies this. The form clearly differentiates between “cause of death” and “mode of death”. The mode of death can be “heart failure, respiratory failure etc”. The ‘etc.’ is significant here because it recognises the fact that there can be other modes of death like BSD. BSD is basically a respiratory failure because of damage to the respiratory centre in the brainstem; the respiratory nucleus in the brain stem is permanently damaged.
Questions around consent
Should life support be continued if the family does not consent for organ donation after BSD certification? The law can only define death, and cannot say what the doctor or the hospital should do after the death of an individual. Where there is consent for organ donation, maintaining such a person on life support is needed to perfuse organs and arrange logistics for organs retrieval. Where there is no such consent, life support may be continued at the request of the family making it clear that the death certificate has been issued already and that the date and time of death is final.
The other related question is: when should the family be approached for consent for organ donation — before or after BSD certification? A careful reading of the 1994 Act and Rules establishes that BSD should be diagnosed and certified whenever it happens, and that this certification process should be complete before the family is even approached for consent for organ donation.
Rule 5(1) of the Act states, “The registered medical practitioner of the hospital having Intensive Care Unit facility, in consultation with transplant coordinator, if available, shall ascertain, after certification of brainstem death of the person in Intensive Care Unit, from his or her near relative……”. Rule 5(2) says, “The above-mentioned duties shall also apply to the registered medical practitioner working in an Intensive Care Unit in a hospital not registered under this Act, from the notification of these rules.”
Additionally, Form 8, which is the ‘Declaration and Consent Form’, is the form that is used to document consent for organ donation from the near relative/person in lawful possession of the dead body. Point 1 of the Form starts, “I have been informed that my relative……has been declared brainstem dead/dead,” while Point 4 states, “I hereby authorise/not authorise removal of his/her body organ(s)..” These provisions establish that BSD should be identified and certified in every hospital with ICU facilities and that consent or otherwise should be recorded in every case, only after the certification of BSD.
Need for amendments
However, at present BSD certification and organ harvesting happen only in registered transplant hospitals or Non Transplant Organ Retrieval Centres (hospitals which do not have a transplant program but are willing to certify BSD and support organ retrieval). Both need prior registration with the Appropriate Authority (AA). Section 14(1) of the 1994 Act states, ”No hospital [including Human Organ Retrieval Centre] shall commence any activity relating to the removal, storage or transplantation of any [human organ or tissue or both] for therapeutic purposes after the commencement of this Act unless such hospital is duly registered under this Act.” This is in contradiction with Rule 5(1) and (2) and needs to be amended to permit BSD identification, certification and organs harvest in all hospitals having ICU facilities. This amendment is required if we are keen to enlarge the donor pool and increase organ availability. Transplant surgery and live donor organ harvest, however, should be permitted only in registered transplant hospitals.
BSD can happen in patients admitted in the ICU due to trauma or haemorrhage. It must be promptly diagnosed and certified in the manner specified like any other mode of death so that it may either progress to organ donation or end of medical care. But there are two issues — one is that two out of four doctors certifying BSD in Form 10 of the 1994 Act have to be approved by an AA. This imposes practical difficulties. No doctor would take pains to apply for approval because it is cumbersome and doesn’t help them in their professional work except for certifying BSD, which is not a frequent occurrence. Many see this approval as a bureaucratic exercise without any rationale because the AA has not laid down any special eligibility criteria for approving doctors for this purpose. It would be better to remove this requirement and clarify that the certifying doctors must be registered medical practitioners in their specialities. Second is that Form 10 of the 1994 Act does not ask for the time of death. A death certificate without the time of death is an incomplete certificate. The Kerala government in 2020, overcame this by issuing a clarification about the time of BSD. It says that ‘time of death is the time the arterial pCO2 reached the target value in the second apnoea test.” It would be good if other States could also issue similar orders.
It is time that such ambiguities end. Clarity is crucial to empower doctors to certify BSD wherever it occurs and enlarge the donor pool.
J. Amalorpavanathan is member, Tamil Nadu State Planning Commission and former member secretary, Transplant Authority of Tamil Nadu.
Published – December 08, 2025 08:30 am IST
